The present disclosure relates generally to pharmaceutically active ingredients and more particularly to a method of making a pharmaceutically active ingredient abuse-prevention device.
Pharmaceutically active ingredients may include various drugs that exhibit opium or morphine-like properties, such as, for example opioids. Opioids are often administered to patients as analgesics, but have many other pharmacological effects, including drowsiness, respiratory depression, mood swings, and mental clouding without loss of consciousness. Opioids act as agonists as they interact with stereospecific and saturable binding sites in the brain and other tissues. Endogenous opioid-like peptides may be present in areas of the central nervous system that may be related to pain perception, movement, mood, behavior, and the regulation of neuroendocrinological functions. Opium contains more than twenty distinct alkaloids, including morphine, codeine and papaverine.
Repeated opioid use may lead to the development of tolerance, physical dependence, and/or psychological dependence (i.e., addiction) thereon. A concern in using opioids for the treatment of pain is the potential development of such tolerance and/or addiction. Another major concern is the transportation of these drugs from the patient to a non-patient for recreational purposes.
Opioid antagonists have been developed to block or reverse the effects of opioid agonists. Opioid antagonists have been used as once-a-day treatments to substantially block the euphoric effects that might be otherwise obtained upon administration of opioids to addicts. While small doses of antagonists may be used to determine whether an individual is physically dependent on a drug, more commonly, antagonists are used to reverse the effects of drugs on individuals who have overdosed.
There have previously been attempts to control the potential abuse of opioids. Particular doses of opioids may be more potent when administered parenterally than when administered orally. Attempts to reduce or prevent abuse have included adding an antagonist to the oral dosage form which is not orally active but which will substantially block the analgesic/euphoric effects of the opioid if an attempt is made to dissolve the opioid and administer it parenterally.
Attempts have also been made to control the potential abuse of opioids contained within inhalation systems. These attempts include some form of “lock and key” to allow a certain patient access to the opioid. However, the potential of abuse remains, as the keys could be shared with others or the device could be tampered with in an attempt to remove the opioid.
As such, it would be desirable to provide an inhalation system that substantially prevents abuse of a pharmaceutically active ingredient contained therein.